A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF 07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,954
- 试验地点
- 168
- 主要终点
- Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
研究概览
简要总结
The purpose of this clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection.
All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind Double Dummy
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-
- •Fertile participants must agree to use a highly effective method of contraception
排除标准
- •History of SARS-CoV-2 infection in the past 6 months
- •Experiencing measured fever (documented temperature >38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19
- •Known medical history of active liver disease
- •Chronic Kidney Disease or have known moderate to severe renal impairment.
- •Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment
- •Suspected or confirmed concurrent active systemic infection
- •Active cancer requiring treatment with prohibited medication.
- •Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
- •Has received approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening
- •Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day
- •Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
- •Known or prior participation in this trial or another trial involving PF-
- •Females who are pregnant or breastfeeding.
研究组 & 干预措施
PF-07321332/ritonavir (5 days)
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10
干预措施: PF-07321332 (Drug)
PF-07321332/ritonavir (5 days)
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10
干预措施: Placebo for PF-07321332 (Drug)
PF-07321332/ritonavir (5 days)
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10
干预措施: Placebo for Ritonavir (Drug)
PF-07321332/ritonavir (5 days)
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10
干预措施: Ritonavir (Drug)
PF-07321332/ritonavir (10-Day)
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.
干预措施: PF-07321332 (Drug)
PF-07321332/ritonavir (10-Day)
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.
干预措施: Ritonavir (Drug)
Placebo
Participants will receive placebo every 12 hours from Day 1 through Day 10.
干预措施: Placebo for PF-07321332 (Drug)
Placebo
Participants will receive placebo every 12 hours from Day 1 through Day 10.
干预措施: Placebo for Ritonavir (Drug)
结局指标
主要结局
Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
时间窗: From Day 1 to Day 14
Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
次要结局
- Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline(From Day 1 to Day 14)
- Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline(From Day 1 to Day 14)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation(From start of study intervention (Day 1) up to end of safety follow-up (Day 38))
- Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness(From Day 1 to Day 14)
- Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline(From Day 1 to Day 14)
- Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline(From Day 1 to Day 28)
- Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline(From Day 1 to Day 38)
- Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline(From Day 1 to Day 14)
- Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness(From Day 1 to Day 28)
- Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline(From Day 1 to Day 14)
- Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline(From Day 1 to Day 14)
- Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline(From Day 1 to Day 28)
- Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)(Day 1: 1 hour post dose; Day 5: 2 hours pre-dose)
- Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline(From Day 1 to Day 28)
- Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline(From Day 1 to Day 28)